MalfunctionDTW
QUANTUM LEVEL SENSOR 2.0M - SINGLE HEAD
Received Oct 17, 2024 · Event occurred Aug 19, 2024
Report 3006073153-2024-00067 · MDR key 20470898
Device
Generic name
Level Sensor
Manufacturer
Spectrum Medical LimitedModel number
QLS1-200Catalog number
51-000069-00
Product problems
- Device Sensing Problem
- Device Sensing Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
SAFE FLOW ALARM STARTED 'FLICKERING' ON AND OFF, AFTER CIRCULATING FLUID FOR AROUND 1.5HR. THE PERFUSIONIST OPTED TO REPLACE THE LEVEL SENSOR BEFORE GOING ON BYPASS.
Additional Manufacturer Narrative
SENSOR TESTED NO FAULT COULD BE REPRODUCED. SENSOR RETURNED TO LTD FOR INVESTIGATION. SENSOR RECALIBRATED AND FIRMWARE UPDATE BY LTD.
Description of Event or Problem
SAFE FLOW ALARM STARTED 'FLICKERING' ON AND OFF, AFTER CIRCULATING FLUID FOR AROUND 1.5HR. THE PERFUSIONIST OPTED TO REPLACE THE LEVEL SENSOR BEFORE GOING ON BYPASS.